Marco Donia: What Should We Watch in Melanoma at ESMO26? 
Marco Donia/LinkedIn

Marco Donia: What Should We Watch in Melanoma at ESMO26? 

Marco Donia, Professor of Clinical Oncology at University of Copenhagen, shared on LinkedIn:

“What Should We Watch in Melanoma at ESMO26? 

As the congress opens in Madrid, my watchlist focuses on individualized vaccination, neoadjuvant treatment, first-line combinations and ADCs after PD-1 therapy.

LBA1  INTerpath-001
Saturday 24 October, 16:30 – 16:42
Phase III evidence for individualized vaccination in resected melanoma. Among 1,137 patients, intismeran autogene + pembrolizumab improved 24-month RFS to 82.2% vs 70.0% (HR 0.58) and DMFS to 88.5% vs 80.2% (HR 0.62).

12.2-percentage-point absolute RFS difference. Median follow-up is 24.6 months; OS is not reported. Longer follow-up and delivery of individualized manufacturing will help define its clinical impact.

2071O STARBOARD
Friday 23 October, 16:15 – 16:25
Encorafenib + binimetinib + pembrolizumab in first-line BRAF V600-mutant melanoma: ORR 70.0% vs 32.7% and median PFS 33.0 vs 3.4 months compared with pembrolizumab alone.

A substantial efficacy signal, with grade 3/4 TEAEs in 70% vs 39%. Control-arm performance, relevance to dual-checkpoint therapy and treatment sequencing (not compared in the study) need discussion.

2076RO  NADINA 3 Year FU

Sunday 25 October, 11:14–11:19
Three-year EFS of 72.9% vs 50.0% and DMFS of 75.3% vs 57.4%, favoring neoadjuvant ipilimumab nivolumab with response-adapted care over surgery followed by adjuvant nivolumab.
Sustained separation at three years, clinically important.

LBA54  HBI-8000-303
Friday 23 October, 16:25–16:35
In 404 patients with unresectable or metastatic, PD-(L)1-naïve melanoma, adding HBI-8000 to nivolumab improved median PFS from 7.4 to 11.7 months: HR 0.73 (96% CI 0.56–0.95).

Benefit comes with additional toxicity: treatment-related adverse events led to discontinuation in 14% vs 5%. OS remains immature.

ADCs after PD-1 therapy
Sunday 25 October
10:15–10:20 2073RO: HER3-DXd
Confirmed responses in 9/42 patients (21%), investigator median DOR 8.0 months and grade ≥3 TRAEs 57%.
10:20–10:25  2074RO: enfortumab vedotin + pembrolizumab
60 patients enrolled, 53 evaluable; confirmed ORR 17%. Grade 3/4 toxicities occurred in 23.3%.

Interesting clinical signals in a setting with substantial unmet need.

TIL and TCR-T in my separate cell-therapy watchlist shortly.

As an ESMO26 Social Media Ambassador, I look forward to the presentations and discussion.”

Marco Donia: What Should We Watch in Melanoma at ESMO26? 

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